510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131396Substantially Equivalent

Wired Mouth Protector (Wmp)

Elba Laboratories, Inc., Ferndale MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131396 is the FDA 510(k) clearance record for WIRED MOUTH PROTECTOR (WMP), a class I device, cleared for Elba Laboratories, Inc. on under FDA product code PFL (Intraoral, Dental Foam Protector). FDA's definition for product code PFL reads: "Intended to provide a soft barrier between wired mouth hardware and oral mucosa". FDA records list one 510(k) clearance for Elba Laboratories, Inc. As of , FDA records show no recalls naming K131396.

Clearance record

Decision date
Received
(138 days to decision)
Product code
PFL Intraoral, Dental Foam Protector
Regulation
21 CFR 872.6890
Device class
Class I
Review panel
Dental
Applicant
Elba Laboratories, Inc. 780 W. 8 Mile Rd., Ferndale MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PFL

Trailing 12 months

FDA records hold no clearances under product code PFL in the trailing twelve months.

FDA records show no clearances under product code PFL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PFL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260